1102 Aplicare Povidone-iodine Scrub

Aplicare Povidone-iodine Scrub by

Drug Labeling and Warnings

Aplicare Povidone-iodine Scrub by is a Otc medication manufactured, distributed, or labeled by Aplicare Products, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

APLICARE POVIDONE-IODINE SCRUB- povidone-iodine solution 
Aplicare Products, LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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1102 Aplicare Povidone-iodine Scrub

Povidone-iodine

Use

antiseptic skin preparation

Ask a doctor before use if injuries are

deep or puncture wounds

serious burns

Stop use and ask a doctor if

  • redness, irritation, swelling or pain persists or increases
  • infection occurs

Do not use

if allergic to iodine

in the eyes

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

For questions, comments, or to report serious side effects:

800 760-3236

Monday-Friday

8:30 a.m.- 5:00 p.m. EST

For external use only

Avoid excessive heat. Store at room temperature.

Other information

0.75% titratable iodine

latex free

for hospital or professional use only

Inactive ingredients

ammonium nonoxynol-4 sulfate

citric acid

disodium phosphate

nonoxynol-9

sodium hydroxide

water

Directions

apply locally as needed

antiseptic

52380-1102

APLICARE

POVIDONE-IODINE SCRUB SWABSTICK

STERILE SOLUTION

APLICARE POVIDONE-IODINE SCRUB 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52380-1102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE7.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 52380-1102-42 mL in 1 PACKET; Type 0: Not a Combination Product01/01/198411/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/198411/01/2019
Labeler - Aplicare Products, LLC. (081054904)
Establishment
NameAddressID/FEIBusiness Operations
Aplicare Products, LLC.081054904manufacture(52380-1102)

Revised: 2/2020
Document Id: 9daf47de-49bd-a8c2-e053-2995a90a99cf
Set id: cbf5b6af-5d06-472d-8c94-544dbbe1400d
Version: 5
Effective Time: 20200203
 
Aplicare Products, LLC.